Humira: the impending patent battles over adalimumab biosimilars-Reference-Cited by-同舟云学术

Humira: the impending patent battles over adalimumab biosimilars

Published:2016-05 Issue:3 Volume:5 Page:141-145
ISSN:2046-8954
Container-title:Pharmaceutical Patent Analyst
language:en
Short-container-title:Pharmaceutical Patent Analyst

Author:

Norman Peter¹

Affiliation:

1. Norman Consulting, 18 Pink Lane, Burnham, Bucks, SL1 8JW, UK

Abstract

The world's top selling drug, adalimumab (AbbVie's Humira), generated sales in excess of US$13 billion in 2015. The primary product patent expires in 2016 in the USA and 2018 in Europe. This has resulted in a rush by companies to develop adalimumab biosimilars and Amgen submitted regulatory filings for its product ABP-501 in late 2015 in both the USA and Europe. AbbVie has claimed its patent portfolio provides product protection until 2022, but an increasing number of patent challenges are being made and the filings for approval of biosimilars will see more challenges made over the next few years.

Publisher

Future Science Ltd

Subject

General Medicine

Link

http://www.future-science.com/doi/pdf/10.4155/ppa-2016-0002

Reference24 articles.

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2. Amgen. Amgen's first biosimilar Biologics License Application For ABP 501 submitted to US Food and Drug Administration. www.amgen.com/media/news-releases/2015/11/amgens-first-biosimilar-biologics-license-application-for-abp-501-submitted-to-us-food-and-drug-administration

3. EMA. Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use. www.ema.europa.eu/docs/en_GB/document_library/Report/2016/01/WC500199649.pdf

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5. Central Drugs Standard Control Organization. 18th SEC (Analgesics, Anesthetics and Rheumatology) Committee meeting. http://cdsco.nic.in/writereaddata/18th%20SEC%20Analgesic%20Agenda%2029_05_2015.pdf

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